Saturday, July 16, 2016 3:07:14 PM
The more important milestones, to me:
- Acceptance by FDA of the NDA (within 2 months of filing, as they have to do a summary review to make sure NDA is in order). This is a major milestone, because an RTF letter from the FDA would be a significant setback in time.
- Partnership. Either they will have to partner or sell shares by the end of the year to get ready for launch. I'm confident they realize doing their own manufacturing and sales is far too dilutive to attempt at current prices, so I expect a partnership before the PDUFA date. Terms would be better if they wait for approval (Q1 '17?), but IMO signing a partnership before approval is much less risky.
- Approval.
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